A Single-Center Open-Label Study of 1064 nm Nd:YAG for Nonablative Skin Rejuvenation

This is a single-center prospective, open-label uncontrolled study in 15 male or female
subjects, age 35 to 55 years who desire non-ablative laser treatment for facial
photo-rejuvenation, specifically improvement of rhytides, lentigines, erythema,
telangiectasia and skin texture. Subjects will receive up to 6 laser treatments spaced 2 to 4
weeks apart and complete two follow-up visits; one at 4 weeks and one at 12 weeks post-final
treatment.

Inclusion Criteria:

1. Female or Male, 35 to 55 years of age (inclusive).

2. Fitzpatrick Skin Type I - IV (Appendix 4).

3. Desires non-invasive and non-ablative treatment of skin-aging or photo-rejuvenation of
the skin.

4. Have signs of moderate skin aging, including presence of mild to moderate rhytides
around eyes and upper lip, multiple lentigines, diffuse erythema or telangiectasia,
and a score between 4 and 7 (inclusive) on the Fitzpatrick Wrinkle Classification
Scale (Appendix 3).

5. Subject must be able to read, understand and sign the Informed Consent Form.

6. Must be willing and able to adhere to the treatment and follow-up schedule and
post-treatment care instructions.

7. Willing to have very limited sun exposure and use an approved sunscreen of SPF 30 or
higher on the treatment area every day for the duration of the study, including the
follow-up period.

8. Willing to have digital photographs taken of the treatment area and agree to use of
photographs for presentation, educational or marketing purposes.

9. Agree to not undergo any other procedure(s) for skin rejuvenation during the study,
including but not limited to chemical peel, laser and light based device treatment,
and home-use device treatment.

10. Agree to not undergo any injection of botulinum toxin, collagen, hyaluronic acid
filler or other dermal filler during the study.

11. Post-menopausal or surgically sterilized, or using a medically acceptable form of
birth control at least 3 months prior to enrollment and during the entire course of
the study, and no plans to become pregnant or to father a child for the duration of
the study.

Exclusion Criteria:

1. Participation in a clinical trial of another device or drug within 6 months prior to
enrollment or during the study.

2. Any type of prior cosmetic treatment to the target area within 6 months of study
participation, such as laser or light-based procedures or surgery.

3. Prior injection to the face of botulinum toxin, collagen, hyaluronic acid filler or
other dermal filler within 6 months of study participation, as applicable.

4. Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable,
within 6 months of study participation.

5. Use of topical medications on the face, such as antibiotics, benzoyl peroxide,
retinoids (isotretinoin), corticosteroids, hydroquinone, or products containing
dihydroxyacetone or alpha-hydroxy with concentration > 8%, within 1 month of
participation.

6. History of malignant tumors in the target area.

7. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large
moles.

8. Pregnant and/or breastfeeding.

9. Having an infection, dermatitis or a rash in the treatment area.

10. Significant concurrent illness, such as diabetes mellitus or cardiovascular disease,
e.g., uncontrolled hypertension.

11. Suffering from coagulation disorders, or taking prescription anticoagulation
medication which might make study participation unsafe according to Investigator's
discretion.

12. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.

13. History of immunosuppression/immune deficiency disorders or currently using
immunosuppressive medications.

14. History of vitiligo, eczema, or psoriasis.

15. History of connective tissue disease, such as systemic lupus erythematosus or
scleroderma.

16. History of seizure disorders due to light.

17. Any use of medication that is known to increase sensitivity to light according to
Investigator's discretion.

18. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes
zoster (shingles) in the treatment area, unless treatment is conducted following a
prophylactic regimen.

19. History of radiation to the treatment area or undergoing systemic chemotherapy for the
treatment of cancer.

20. History of pigmentary disorders, particularly tendency for hyper- or
hypo-pigmentation.

21. Anytime in life, having have used gold therapy (gold salts) for disorders such as
rheumatologic disease or lupus.

22. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning
during the study.

23. Current smoker or history of smoking within 6 months of study participation.

24. As per the Investigator's discretion, any physical or mental condition which might
make it unsafe for the subject to participate in this study.